English 
Hitachi, Ltd. has entered a licensing agreement with Shionogi & Co., Ltd. to roll out a generative AI solution that supports the creation of regulatory documents in drug development. The solution has been available to pharmaceutical and healthcare companies in Japan since February 2026, with plans to position it under Hitachi’s Lumada portfolio going forward.
The tool focuses on one of the most time-consuming tasks which occurs during the drug development process. The team needs to create clinical trial protocols and reports that meet international standards including ICH-E6 and ICH-E3. These documents compile massive volumes of clinical data and demand precision.
In a proof of concept conducted at Shionogi, the system reduced preparation time for clinical trial reports by about 50 percent and for clinical trial protocols by roughly 20 percent. Many users reported an overall reduction in workload.
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The solution combines Hitachi’s experience in generative AI and pharmaceutical IT and OT with 塩野義製薬’s medical writing expertise and data science capabilities. It can extract and summarize relevant information from large volumes of mixed Japanese and English clinical data and generate initial drafts through an intuitive interface.
The larger play is productivity. Faster documentation means shorter development cycles. Shorter cycles mean quicker delivery of medicines. 日立 also plans to expand this approach into the biopharmaceutical space as part of its broader industry automation strategy under Lumada.
日本語